The Low level Laser model Strawberry and Strawberry and Cream can be used for the non-invasive temporary reduction in waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

Device Description

The Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system consists of a control unit, various connection leads up to 10 paddles, 2 probes, various "Velcro" attachment straps and other accessories. A paddle is a device containing six cold red laser emitting diodes which is designed to be placed on the skin. The system can operate using 4, 6, 8 or 10 paddles that are connected to the control unit. A probe is a device containing one cold red laser emitting diode which is designed to be placed on the skin to treat specific smaller areas of fat, where a usual flat paddle won't ergonomically fit. The control unit is an electrically powered unit (100-240v, 50-60Hz auto-ranging). enabled by a main switch and key switch. Once enabled it is controlled using a button (Strawberry) or touchscreen (Strawberry and Cream) interface. The output of the diode (six per paddle) is limited to 40mW +/- 15% by a power limiting PCB from the central processing unit.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Laser Lipo Ltd Strawberry Low Level Laser System

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Technical Performance
Laser Diode Power Output (Paddle)	40 mW +/- 15% (34 mW - 46 mW)	Mean: 39.35 mW (Capability, Cp: 2.47)
Laser Diode Power Output (Probe)	40 mW +/- 15% (34 mW - 46 mW)	Mean: 39.02 mW (Capability, Cp: 3.49)
EU Portable Appliance Testing	100% Pass	100% Pass
Visual Inspection	100% Pass (external components, cables, outer casings, general condition of all associated parts)	100% Pass
Assembly Tests	100% Pass	100% Pass
Functionality Tests	100% Pass	100% Pass
Clinical Performance (Efficacy)
Temporary Reduction in Abdomen Circumference	95% of actively treated subjects achieve a temporary reduction of 1.6 inches (4 cm) or more around the abdomen (at the height of the iliac crest).	95% of actively treated subjects met the criteria. Average recorded loss: 3.68 inches (9.35 cm). Greatest loss: 5.6 inches (14.22 cm). One out of 22 treated subjects failed (1.2 inches reduction).
Placebo Response (Abdomen Circumference)	Placebo subjects should not achieve a reduction greater than 1.3 inches (3.3 cm).	Not one of the placebo subjects achieved more than 1.3 inches (3.3 cm) reduction.
Adverse Effects	No adverse events expected.	No adverse effects were experienced by any of the trial subjects.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Study Test Set: 35 subjects total. 22 subjects received active laser treatments, and 13 subjects received placebo treatments.
Technical Performance Test Sets:
- Laser diode power output (paddle): 1140 samples
- Laser diode power output (probe): 40 samples
- EU portable appliance testing: 20 units
- Visual Inspection: 20 units
- Assembly Tests: 20 units
- Functionality Tests: 20 units
Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, based on the submission to the CDRH (an arm of the FDA in the USA) by a UK-based company, it's likely the clinical study was conducted with a view towards US regulatory clearance. The clinical study is described as a "full double blind clinical study," which suggests it was prospectively designed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the clinical study beyond the measurement of waist circumference. For the technical performance tests, it appears standard engineering and quality control measurements were performed.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method beyond the direct measurement of waist circumference. In a double-blind study, the "ground truth" for efficacy is the measured change in circumference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study was a comparison between active treatment and placebo, focusing on the device's efficacy in reducing waist circumference.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This device is a physical low-level laser system for aesthetic use, not a diagnostic algorithm or AI-driven system operating without human interaction. Therefore, the concept of a "standalone" or "algorithm-only" performance study is not applicable. The performance described relates to the physical device and its clinical effect.

7. The Type of Ground Truth Used

Clinical Studies: The ground truth for efficacy was quantitative physiological measurement (temporary reduction in waist circumference, measured in inches/cm).
Technical Performance: The ground truth for technical tests was based on direct measurement against specified engineering tolerances (e.g., laser power output, electrical safety, visual inspection, assembly, functionality).

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of an AI/ML algorithm. This device is a physical medical device. The "training" for such devices would involve manufacturing process controls and calibration, not data-driven algorithm training.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, the concept of a "training set" for an algorithm and its associated ground truth is not applicable to this physical low-level laser device.

Summary

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K13034
September 05, 2013

Center for Devices and Radiological Health

Laser Lipo Ltd Heath House, Crockham Hill Edenbridge United Kingdom, TN8 6ST Telephone: +44 844 980 1820 e-mail: ian@strawberry-laser.com

ﻏﺴ

Image /page/0/Picture/3 description: The image shows a black and white drawing of a strawberry. The strawberry is depicted with its characteristic shape and texture, including the small seeds on its surface. The top of the strawberry has a leafy green stem. The drawing style is somewhat rough, with visible strokes and shading that give the strawberry a three-dimensional appearance.

510[k] Summary

as required by section 807.92(c)

Owner's Name SEP 0 6 2013 Laser Lipo Ltd Address: Heath House Crockham Hill Edenbridge Kent TN8 6ST United Kingdom Tel: 011 44 844 980 1820 Mobile: 011 44 777 445 9611 Fax: 011 44 1732 866 231 Contact Person: Ian Cobley at Laser Lipo Ltd Tel : 011 44 844 980 1820 011 44 777 445 9611 Mobile: Fax: 011 44 844 980 1820 ian@strawberry-laser.com E-mail: . Date this summary was prepared: January 31, 2013

Classification name: Low Level laser system for aesthetic use, 21 CFR 878.5400 79 OLI

Common/Usual Name: Low Level laser system for aesthetic use

Proprietary Name: Laser Lipo Ltd will manufacture two devices:

The Strawberry low level laser system model ILO, and, ●
The Strawberry & Cream low level laser system model SC �

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, t

Establishment Registration Number:

The Strawberry low level laser system and Strawberry & Cream low level laser system will be manufactured by: Laser Lipo Ltd

Heath House Crockham Hill Edenbridge Kent TN8 6ST United Kingdom 011 44 844 980 1820 011 44 844 980 1820

Establishment Registration Number: To be applied for following clearance of this submission.

Substantial Equivalence: The Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system is substantially equivalent in design, use and materials to the: Chromogenex Technologies Ltd I-Lipo System - K111501

. They are made of the similar materials
Telephone:

Fax:

They have similar indications for use that are achieved through the same . technology
0 They are assembled from similar components
They have similar user input and output interfaces and .
Have similar features. .

In particular both the Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system and the Chromogenex Technologies Ltd i-Lipo System:

use laser diodes .
- o of approximately 660 nm wavelength, and
- o less than 50 mW output
. incorporated into
- o multiple multi-diodes "paddles" attached to the subject with special straps

Strawberry 4 to 10 paddles with 6 diodes each i-Lipo 4 paddles with 9 diodes each

o and both have two probes with one diode each
� have a similar control unit
- o LCD subject display
- o membrane key pad inputs

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ﺗ

0 incorporated into display as a touch screen for strawberry and cream o microprocessor controlled through software
- o multi-range power supply (EU and US voltages and frequencies)
. have a similar range of connecting cables
have the same laser protection goggles ●
- o different name printed on outside of frame

Description of Product:

A paddle is a device containing six cold red laser emitting diodes which is designed to be placed on the skin. The system can operate using 4, 6, 8 or 10 paddles that are connected to the control unit.

A probe is a device containing one cold red laser emitting diode which is designed to be placed on the skin to treat specific smaller areas of fat, where a usual flat paddle won't ergonomically fit.

The control unit is an electrically powered unit (100-240v, 50-60Hz auto-ranging). enabled by a main switch and key switch. Once enabled it is controlled using a button (Strawberry) or touchscreen (Strawberry and Cream) interface. The output of the diode (six per paddle) is limited to 40mW +/- 15% by a power limiting PCB from the central processing unit.

When the laser paddles are placed on the skin, the cold red laser beams penetrate the skin just deep enough to reach the layers of fat. When the light hits the fat cells, a rapid chain of events takes place. Firstly, pores form on the cells causing them to spill out. The water, Glycerol and fatty acids move into the interstitial space beneath the fatty layer in the skin. Then further water, fatty acids and Glycerol spill out. The adipocyte cells are therefore reduced in size.

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Intended use:

Performance Data:

Laser wavelength and output has been demonstrated to be capable and substantially equivalent to the predicate device (Chromogenex i-Lipo, K 111051).

Test	Mean	Quantity	SampleStandardDeviation	Capability,Cp
Laser diode power output:Paddle Laser diode outputis set to 40mw +/-15%.	39.35	1140	0.81	2.47
Probe Laser diode outputis set to 40mw +/-15%.	39.02	40	0.72	3.49
EU portable appliancetesting	100% pass	20
Visual Inspection:• external components,cables, outer casingsand the• General condition ofall associated parts.	100% pass	20		100%inspection
Assembly tests	100% pass	20		100%inspection
Functionality tests	100% pass	20		100%inspection

Double blind clinical study: Laser Lipo Ltd, at the request of the CDRH, had a full double blind clinical study carried out using a total of 35 subjects. Of these, 22 subjects received active laser treatments, and the remaining 13 subjects received placebo treatments. (See section 20.)

Conclusions: At the conclusion of the study, it was clear that 95% of the actively treated subjects achieved, or met, the success criteria. The criteria was set as achieving a temporary reduction around the subjects abdomen (at the height of the iliac crest) of 1.6in (4cm). The average recorded loss was 3.68in (9.35cm) with the greatest loss at 5.6in (14.22cm). Out of the 22 treated subject one failed to met the criteria with a reduction of only 1.2in (3cm). Thus proving the efficacy of the Strawberry and Strawberry & Cream inch loss device.

Not one of the placebo subjects achieved more than 1.3in (3.3cm).

No adverse effects were experienced by any of the trial subjects.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, clutching a caduceus in its talons. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002

September 6, 2013

Laser Lipo Ltd Mr. Ian Coblev Heath House, Crockham Hill Edenbridge. Kent TN8 6ST United Kingdom

Re: K130341

Trade/Device Name: Laser Lipo Ltd Strawberry Low Level Laser system and Strawberry and Cream Low level Laser system Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OLI Dated: July 26. 2013 Received: July 29, 2019

Dear Mr. Cobley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Ian Cobley

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default,htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130341

Device Name: Laser Lipo Ltd Strawberry Low Level Laser system and Strawberry and Cream Low level Laser system

Indications for Use: The Low level Laser model Strawberry and Cream can be used for the non-invasive temporary reduction in waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

Prescription Use __ X_

AND/OR

Over-The-Counter Use

{Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.09.06 11:33:42 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number_K130341

Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.